NDC 63323-024

Mannitol

Mannitol

Mannitol is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Mannitol.

Product ID63323-024_9491f22f-5d6b-77d9-e053-2995a90a9a1e
NDC63323-024
Product TypeHuman Prescription Drug
Proprietary NameMannitol
Generic NameMannitol
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2000-03-19
Marketing CategoryANDA / ANDA
Application NumberANDA080677
Labeler NameFresenius Kabi USA, LLC
Substance NameMANNITOL
Active Ingredient Strength250 mg/mL
Pharm ClassesIncreased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63323-024-25

25 VIAL, SINGLE-DOSE in 1 TRAY (63323-024-25) > 50 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2000-03-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-024-29 [63323002429]

Mannitol INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA080677
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-03-19
Marketing End Date2015-09-30

NDC 63323-024-25 [63323002425]

Mannitol INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA080677
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-03-19

NDC 63323-024-05 [63323002405]

Mannitol INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA080677
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-03-19
Marketing End Date2012-11-19

Drug Details

Active Ingredients

IngredientStrength
MANNITOL250 mg/mL

OpenFDA Data

SPL SET ID:c395e13d-6ea1-4104-8b37-669cfb982f04
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311450
  • UPC Code
  • 0363323024253
  • Pharmacological Class

    • Increased Diuresis [PE]
    • Osmotic Activity [MoA]
    • Osmotic Diuretic [EPC]

    NDC Crossover Matching brand name "Mannitol" or generic name "Mannitol"

    NDCBrand NameGeneric Name
    0264-2303MannitolMannitol
    0264-7578MannitolMANNITOL
    0404-9905MannitolMannitol
    0409-4031MannitolMANNITOL
    0409-7715MannitolMANNITOL
    0990-7715MannitolMANNITOL
    51662-1468MANNITOLMANNITOL
    52584-031MannitolMannitol
    63323-024MannitolMANNITOL
    67850-552Aridol Bronchial Challenge Test Kitmannitol
    10122-212Bronchitolmannitol
    62171-100GD11 Rx SCM C5MANNITOL
    0338-0351OsmitrolMannitol
    0338-0353OsmitrolMannitol
    0338-0355OsmitrolMannitol
    0338-0357OsmitrolMannitol

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